The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Tri-fit Femoral Stem.
| Device ID | K010243 |
| 510k Number | K010243 |
| Device Name: | TRI-FIT FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel K Batts |
| Correspondent | Joel K Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-25 |
| Decision Date | 2001-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055196963078 | K010243 | 000 |
| 05055196963061 | K010243 | 000 |
| 05055196963054 | K010243 | 000 |
| 05055196963047 | K010243 | 000 |
| 05055196963030 | K010243 | 000 |
| 05055196963023 | K010243 | 000 |